CONVERTING CENTRALLY AUTHORISED PRODUCTS (CAPS) TO UK MARKETING AUTHORISATIONS (MAS)
After Brexit became effective on 1st January 2021, all existing EU product MAs obtained through Centralized procedure (CAP) have been…
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SWISS AUTHORISED REPRESENTATIVE – INFORMATION FOR DISTRIBUTORS AND IMPORTERS: AN UPDATED GUIDANCE DOCUMENT FROM SWISS MEDTECH
Following the entry into force of the EU Regulation 2017/745 on medical devices in May 2021 and following the failure…
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IMPD GUIDELINE UPDATE
Since clinical trials are often designed as multi-centre studies, potentially involving different Member States, on March 2006 the European Medicines…
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FDA GUIDANCE ON BISPECIFIC ANTIBODY DEVELOPMENT
Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…
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AIR PURIFIERS AND AIR DECONTAMINATORS: ARE THEY MEDICAL DEVICES OR NOT?
In the context of the COVID-19 pandemic, great attention is given to the sanitation measures of people and environments. People…
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FDA GUIDANCE ADDRESSES PATIENT OUTCOMES IN CANCER CLINICAL TRIALS
Involvement of patients is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. Patients have been…
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NEW AIFA PRICING AND REIMBURSEMENT E-DOSSIER PORTAL GOES LIVE
A new electronic interface for the preparation of Pricing and Reimbursement e-Dossiers has been developed by AIFA and has become available since 31st May…
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5% PAYBACK – LATEST NEWS
In Italy, with a few exceptions, the public price (VAT included) of medicines reimbursed by the NHS is subject to…
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CLINICAL TRIALS – UPDATE OF SUBMISSION PROCEDURE AND AUTHORIZATION FORMS
The Italian Medicines Agency (AIFA) has published an update concerning the documentation for the submission of Phase I, II, III…
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PHARMACOVIGILANCE – MANAGEMENT OF REPORTS OF LACK OF EFFICACY IN THE NATIONAL PHARMACOVIGILANCE NETWORK
The Italian Medicines Agency (AIFA), in line with what is reported in the Guideline on good pharmacovigilance practices (GVP) Module…
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